MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number 1011707-15

Device Problems Detachment Of Device Component (1104); Unstable (1667)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2014

Event Type  malfunction  

Event Description

It was reported that during a procedure of the mildly tortuous, mildly calcified, de novo, mid left anterior descending artery a balance middleweight universal ii (bmw uii) guide wire was positioned across the lesion and pre-dilatation completed with a 2.0 x 8 mm mini trek balloon dilatation catheter.A 2.5 x 15 mm xience prime stent was advanced but the proximal shaft broke and the stent became partially dislodged prior to reaching the lesion.The device was removed with the stent implant.A second 2.5 x 15 mm xience prime stent was used successfully in the procedure.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The stent implant was stationary on the balloon between the markers, with a flared proximal strut.The hypotube was kinked, not separated.The reported shaft detachment was unable to be confirmed.The reported unstable stent was unable to be confirmed.Based on a visual and dimensional inspection of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query of the complaint database revealed no other similar incidents reported for detachment of device component or unstable stent from this lot.Based on the reviewed information, no product deficiency was identified.

• Brand Name: XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 4317914
• MDR Text Key: 5246680
• Report Number: 2024168-2014-08076
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2015
• Device Catalogue Number: 1011707-15
• Device Lot Number: 2121941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GUIDE WIRE: BALANCE MIDDLEWEIGHT UNIVERSAL II